Long-Term Extrapolation of Clinical聽Benefits Among Patients With聽Mild聽Heart聽Failure Receiving Cardiac聽Resynchronization Therapy: Analysis of the 5-Year Follow-Up From the REVERSE Study

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• 作者：Michael R. Gold ; MD ; PhD^&lowast ; ; ^{goldmr@musc.edu" class="auth_mail" title="E-mail the corresponding author} ; Amie Padhiar ; MSc^&dagger ; ; Stuart Mealing ; MSc^&dagger ; ; Manpreet K. Sidhu ; MBA ; PhD^&Dagger ; ; Stelios I. Tsintzos ; MD ; MSc^§ ; ; William T. Abraham ; MD^鈥?/sup>
• 关键词：cardiac resynchronization therapy ; health economics ; heart failure ; health policy ; rank-preserving structural failure time
• 刊名：JACC: Heart Failure
• 出版年：2015
• 出版时间：September 2015
• 年：2015
• 卷：3
• 期：9
• 页码：691-700
• 全文大小：755 K

文摘

This study sought to assess the lifelong extrapolated patient outcomes with cardiac resynchronization therapy (CRT) in mild heart failure (HF), beyond the follow-up of randomized clinical trials (RCTs).

Background

RCTs have demonstrated short-term survival and HF hospitalization benefits of CRT in mild HF. We used data from the 5-year follow-up of the REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) study to extrapolate survival and HF hospitalizations. We compared CRT-ON versus CRT-OFF and CRT defibrillators (CRT-D) versus CRT pacemakers (CRT-P).

Methods

Multivariate regression models were used to estimate treatment-specific all-cause mortality, disease progression, and HF-related hospitalization rates. Rank-preserving structural failure time (RPSFT) models were used to adjust for protocol-mandated crossover in the survival analysis.

Results

CRT-ON was predicted to increase survival by 22.8% (CRT-ON 52.5% vs. CRT-OFF 29.7%; hazard ratio [HR]: 0.45; p = 0.21), leading to an expected survival of 9.76 years (CRT-ON) versus 7.5 years (CRT-OFF). CRT-D showed a significant improvement in survival compared with CRT-P (HR: 0.47; 95% confidence interval [CI]: 0.25 to 0.88; p = 0.02) and were predicted to offer 2.77 additional life-years. New York Heart Association (NYHA) functional class II patients had a 30.6% higher HF hospitalization risk than class I (I vs. II incident rate ratio [IRR]: 0.69; 95% CI: 0.57 to 0.85; p < 0.001) and 3 times lower rate compared with class III (III vs. II IRR: 2.98; 95% CI: 2.29 to 3.87; p < 0.001).

Conclusions

RPSFT estimates yielded results demonstrating clinically important long-term benefit of CRT in mild HF. CRT was predicted to reduce mortality, with CRT-D prolonging life more than CRT-P. NYHA functional class I/II patients were shown to have a significantly reduced risk of HF hospitalization compared with class III, leading to CRT reducing HF hospitalization rates.